Type 2 Diabetes
Conditions
Brief summary
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
Detailed description
Study Classification: Safety, Pharmacokinetics/dynamics
Interventions
DRUGPlacebo
capsule, Oral, 0.0mg, twice daily, 14 day
DRUGBMS-820132
Capsule, Oral, 15mg, twice daily, 14 day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile). * Diagnosis of type 2 diabetes treated with metformin monotherapy (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months. * Body Mass Index (BMI) of 18.5 to 40 kg/m2. * Fasting glucose in the range of 125-275 mg/dL. * Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%. * Fasting C-peptide \> 1 ng/mL.
Exclusion criteria
* Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism. * History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness. * Any major surgery within 4 weeks of study drug administration. * Any gastrointestinal surgery that could impact upon the absorption of study drug. * Smoking more than 10 cigarettes per day. * Recent drug or alcohol abuse. * Women who are pregnant or breastfeeding. * Positive urine screen for drugs of abuse. * Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments. | Throughout the study drug administration period (14 days) |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) of BMS-820132 | Day 1 and Day 14 |
| Trough observed plasma concentration (Cmin) of BMS-820132 | Day 1 through Day 14 (selected days) |
| Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132 | Day 1 and Day 14 |
| Maximum observed plasma concentration (Cmax) of BMS-820132 | Day 1 and Day 14 |
| Half life (T-Half) of BMS-820132 | Day 14 |
| AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis | Day -1, Day 1, Day 7 and Day 14 |
| Accumulation index (AI) of BMS-820132 | Day 14 |
Countries
United States
Outcome results
None listed